cobas c 501 and c 502 analyzers and

cobas c 311 analyzer

Within-Run Precision Guidelines
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche.

©2012-2014 Roche

Roche Diagnostics
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P.O. Box 50457
Indianapolis, IN 46250-0457
USA
www.roche.com
www.usdiagnostics.roche.com
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1658-07-1014
Distribution in USA by: Roche Diagnostics, Indianapolis, IN

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Revision History
Revisions to this document are provided by Roche when necessary. No part of this document may be
reproduced in any form or by any means without prior written consent.

Publication Reference Number Date Revision purpose

1658-00-0806
November 2010 Document creation
Version 0

1658-01-0307
March 2007 Added ISE data.
Version 1

1658-02-0807
August 2007 Revised for reagent launches.
Version 2

1658-03-0708
July 2008 Revised for reagent launches.
Version 3

1658-04-1208
December 2008 Added Cystatin C.
Version 4

1658-05-0409
April 2009 Added cobas c 311 analyzer
Version 5

1658-06-1209
December 2009 Revised for reagent launches.
Version 6

1658-07-1014
October 2014 Added cobas c 502 analyzer and new reagent launch data
Version 7

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 cobas c 501 and c 502 analyzers and cobas c 311 Within Run Precision Guidelines
Clinical Chemistry
How to use these guidelines:

Where the SD and CV% information is provided, the SD specification is used to determine pass/fail criteria
if the actual sample concentration is below the stated sample concentration in the table. If the actual sample
concentration is equal to or above the stated sample concentration in the table, the CV% specification is used
to determine pass/fail criteria.

Sample %CV
Clinical Chemistry SD
Concentration Guideline
Albumin BCP < 0.07 g/dL 3.5 g/dL <2%
Alk Phos/IFCC gen. 2 < 2 U/L 100 U/L <2%
ALT < 0.9 U/L 30 U/L <3%
ALT/P-5-P < 1.0 U/L 35 U/L <3%
Ammonia < 4.3 µg/dL 85 µg/dL <5%
p-Amylase/EPS (serum) < 1 U/L 50 U/L <2%
p-Amylase/EPS (urine) < 11 U/L 350 U/L <3%
t-Amylase/EPS (serum/plasma) < 2 U/L 100 U/L <2%
t-Amylase/EPS (urine) < 14 U/L 460 U/L <3%
AST < 0.9 U/L 30 U/L <3%
AST/P-5-P < 1.0 U/L 35 U/L <3%
Bilirubin Total Gen.3 < 0.03 mg/dL 0.99 mg/dL <3%
Bilirubin, Total-Special < 0.03 mg/dL 1.0 mg/dL <3%
Bilirubin, Direct < 0.01 mg/dL 0.3 mg/dL <3%
Calcium Gen.2 (serum, urine, STAT, routine) < 0.16 mg/dL OR <2%
Calcium (serum/plasma) < 0.16 mg/dL 8.8 mg/dL <2%
Calcium (urine) < 0.16 mg/dL 8.8 mg/dL <2%
Cholesterol/HP Gen.2 < 3.87 mg/dL 201 mg/dL <2%
Cholinesterase/butyrylthiocholine < 40 U/L --- <2%
CK Liquid < 3 U/L 140 U/L <2%
CK-MB < 0.8 U/L 25 U/L <3%
CO2-L < 0.7 mmol/L 22 mmol/L <3%
Creatinine Plus ver 2 (serum/plasma) < 0.02 mg/dL 0.9 mg/dL <2%
Creatinine Plus ver 2 (urine) < 0.85 mg/dL 28 mg/dL <3%
Creatinine/Jaffe, rate blanked, compensated (serum/plasma) < 0.03 mg/dL 0.9 mg/dL <3%
Creatinine/Jaffe, rate blanked, compensated (urine) < 0.85 mg/dL 28 mg/dL <3%
Creatinine/Jaffe STAT, compensated (serum/plasma) < 0.03 mg/dL 0.9 mg/dL <3%
Creatinine/Jaffe STAT, compensated (urine) < 0.85 mg/dL 28 mg/dL <3%
Cystatin C < 0.04 mg/L 0.8 mg/L <4%
Ethyl Alcohol (serum/plasma/urine) < 1.84 mg/dL 100 mg/dL <2%

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cobas c 501 and c 502 analyzers and cobas c 311 Within Run Precision Guidelines
Clinical Chemistry

Sample %CV
Clinical Chemistry SD
Concentration Guideline
GGT ver 2 < 0.8 U/L 40 U/L <2%
Glucose/HK gen. 3 (serum/plasma) < 1.4 mg/dL 70 mg/dL <2%
Glucose/HK ver 3 (CSF) < 0.7 mg/dL 40 mg/dL <2%
Glucose/HK ver 3 (urine) < 0.5 mg/dL 19.8 mg/dL <3%
HDL-C plus gen 3 < 1.16 mg/dL 38.7 mg/dL <3%
Iron gen 2 < 3.0 µg/dL 150 µg/dL <2%
Lactate gen 2 (plasma) < 0.36 mg/dL 19.8 mg/dL <2%
Lactate gen 2 (CSF) < 0.63 mg/dL 19.8 mg/dL <3%
LDH ver. 2 < 4 U/L 200 U/L <2%
LDL-C Plus gen 2 < 3.1 mg/dL 155 mg/dL <2%
Lipase < 1.2 U/L 60 U/L <2%
Magnesium gen. 2 (serum/plasma) < 1.7 mg/dL 2.43 mg/dL <2%
Magnesium gen. 2 (urine) < 0.17 mg/dL 4.13 mg/dL <3%
Magnesium (serum/plasma) < 0.05 mg/dL 1.7 mg/dL <2%
Magnesium (urine) < 0.17 mg/dL 4.1 mg/dL <3%
Phosphorus (serum/plasma) < 0.06 mg/dL 2.70 mg/dL <2%
Phosphorus (urine) < 1.2 mg/dL 40 mg/dL <3%
Total Protein < 0.13 g/dL 6.6 g/dL <2%
Total Protein U/CSF (CSF) < 14 mg/L 450 mg/L <3%
Total Protein U/CSF (Urine) < 3.6 mg/L 120 mg/L <3%
Triglycerides/GPO < 4.4 mg/dL 203.6 mg/dL <2%
UIBC (serum/plasma) < 13.42 µg/dL 335 µg/dL <4%
Urea/BUN (serum/plasma) < 0.48 mg/dL 23.3 mg/dL <2%
Urea/BUN (urine) < 14 mg/dL 420 mg/dL <3%
Uric Acid ver. 2 (serum/plasma) < 0.1 mg/dL 7.0 mg/dL <2%
Uric Acid ver. 2 (urine) < 2.8 mg/dL 92 mg/dL <3%

n = 21 for all tests

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 cobas c 501 and c 502 analyzers and cobas c 311 Within Run Precision Guidelines
Ion Selective Electrodes (ISE)

Sample %CV
ISE SD
Concentration Guideline
Chloride (serum/plasma) < 100 mmol/L 100 mmol/L < 2.0%
Chloride (urine) < 2.2 mmol/L 110 mmol/L < 2.0%
Potassium (serum/plasma) < 0.08 mmol/L 4.0 mmol/L < 2.0%
Potassium (urine) < 0.75 mmol/L 25.0 mmol/L < 3.0%
Sodium (serum/plasma) < 2.7 mmol/L 135.0 mmol/L < 2.0%
Sodium (urine) < 1.2 mmol/L 40.0 mmol/L < 3.0%

n = 21 for all tests

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Specific Proteins

Sample %CV
Specific Proteins SD
Concentration Guideline
α1-Acid Glycoprotein Gen.2 < 0.05 g/L 1.2 g/L <4%
α1-Antitrypsin, ver.2 < 4.0 mg/dL 90 mg/dL <4%
Antistreptolysin O < 4 IU/mL 100 IU/mL <4%
Apolipoprotein A-1 ver.2 < 4.0 mg/dL 100 mg/dL <4%
Apolipoprotein B ver.2 < 4.0 mg/dL 100 mg/dL <4%
Albumin TQ (urine) < 0.14 g/dL 3.5 g/dL <4%
Albumin TQ (serum) < 0.8 mg/L 20 mg/L <4%
Albumin TQ (CSF) < 10 mg/L 240 mg/L <4%
β2-Microglobulin < 0.09 mg/L 2.2 mg/L <4%
< 0.08 mg/L 0.3 - 1.4 mg/L ---
C-Reactive Protein Gen.3 > 1.4 - 5 mg/L <7%
> 5 mg/L <5%
C-Reactive Protein (Latex) < 0.2 mg/L 5.0 mg/L <4%
Cardiac C-Reactive Protein (Latex) High Sensitive1 < 0.04 mg/L 1.0 mg/L <4%
Ceruloplasmin < 0.8 mg/dL 20 mg/dL <4%
Complement C3c ver.2 < 4.0 mg/dL 90.0 mg/dL <4%
Complement C4 ver.2 < 0.4 mg/dL 10.0 mg/dL <4%
< 0.04 µg FEU/mL 0.5 - 1.7 µg FEU/mL <7%

D-Dimer 1.7 - 3.4 µg FEU/mL <4%

> 3.4 µg FEU/mL <3%

Ferritin Gen.3 < 2.0 ng/mL 40 ng/mL <5%

< 1.5 ug/L 15 ug/L ---
Ferritin Gen.4 --- 15 - 40 ug/L < 10%
--- > 40 ug/L <5%
Fructosamine < 6 µmol/L 285 µmol/L <2%
Haptoglobin ver.2 < 1.2 mg/dL 30.0 mg/dL <4%
Homocysteine Enzymatic Assay < 0.75 µmol/L 15 µmol/L <5%
HbA1c II (whole blood) < 0.25% HbA1c 5% HbA1c <4%
HbA1c II (Hemolysate) < 0.25% HbA1c 5% HbA1c <4%
IgA Gen.2 standard < 3.0 mg/dL 70 mg/dL <4%
IgA Gen.2 sensitive < 2.0 mg/dL 40 mg/dL <4%
IgG Gen.2 standard < 30 mg/dL 700 mg/dL <4%
IgG Gen.2 sensitive (CSF) < 0.08 mg/dL 1.5 mg/dL <5%
IgM Gen.2 standard < 2.0 mg/dL 40 mg/dL <4%
IgM Gen.2 sensitive < 1.0 mg/dL 20 mg/dL <4%

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 cobas c 501 and c 502 analyzers and cobas c 311 Within Run Precision Guidelines
Specific Proteins

Sample %CV
Specific Proteins SD
Concentration Guideline
Lipoprotein (a) Gen.2 < 1.2 mg/dL 30 mg/dL <4%
Myoglobin < 2.4 ng/mL <4%
Myoglobin Gen.2 < 2.4 ng/mL OR <4%
Prealbumin < 2.0 mg/dL 40 mg/dL <4%
Rheumatoid Factors II < 0.6 IU/mL 14 IU/mL <4%
Soluble Transferrin Receptor (sTfR) < + 0.1 mg/L2 2 mg/L <4%
Transferrin ver.2 < 10 mg/dL 200 mg/dL <4%

1 Assay is not available on the cobas c 311 analyzer.

2 This is not an SD, it is an absolute value. At values less than or equal to 2 mg/L, each replicate should be within
± 0.1 mg/L.

n = 21 for all tests

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cobas c 501 and c 502 analyzers and cobas c 311 Within Run Precision Guidelines
Drugs of Abuse Testing

%CV
Drugs of Abuse Testing Semiquantitative Assays Sample Concentration
Guideline
Amphetamines cutoff 1000 ng/mL <8%
Amphetamines cutoff 500 ng/mL <8%
Barbiturates Plus cutoff 200 ng/mL <8%
Benzodiazepines Plus cutoff 100 ng/mL <8%
Benzodiazepines Plus cutoff 200 ng/mL <8%
Benzodiazepines Plus cutoff 300 ng/mL <8%
Cannabinoids II cutoff 20 ng/mL <8%
Cannabinoids II cutoff 50 ng/mL <8%
Cannabinoids II cutoff 100 ng/mL <8%
Cocaine II1 cutoff 150 ng/mL <8%
Cocaine II1 cutoff 300 ng/mL <8%
LSD1 cutoff 0.5 ng/mL <8%
Methadone II cutoff 300 ng/mL <8%
Methadone Metabolite cutoff 100 ng/mL <7%
Methadone Metabolite cutoff 300 ng/mL <7%
Methaqualone cutoff 300 ng/mL <8%
Opiates II cutoff 300 ng/mL <8%
Opiates II cutoff 2000 ng/mL <8%
Oxycodone cutoff 100 ng/mL <7%
Oxycodone cutoff 300 ng/mL <7%
Phencyclidine Plus cutoff 25 ng/mL <8%
Propoxyphene Plus cutoff 300 ng/mL <8%

1 Assay is not available on the cobas c 311 analyzer.

n = 21 for all tests

Qualitative DAT Precision Mode

To run precision on a qualitative DAT, set the S1 ABS to 0 (zero) and the K factor to 1000. Do not run a STD 1
calibrator. Results display in absolute milliabsorbance. After running the precision, reset the K factor to -1000
and recalibrate, using STD 1, prior to assaying samples.

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Therapeutic Drug Monitoring

Sample %CV
Therapeutic Drug Monitoring SD
Concentration Guideline
Acetaminophen < 0.8 µg/mL 10.0 µg/mL <7%
Acetaminophen (cobas c 311 analyzer) < 0.6 µg/mL 10.0 µg/mL <5%
Amikacin < 0.56 µg/mL 8.0 µg/mL <7%
Carbamazepine III < 0.25 µg/mL 5 µg/mL <5%
Digoxin < 0.1 ng/mL 1.0 ng/mL <7%
Gentamicin II1 < 0.09 µg/mL 1.7 µg/mL <5%
Lithium < 0.03 mmol/L 1.0 mmol/L <3%
NAPA < 0.14 µg/mL 2 µg/mL <7%
Online Phenobarbital < 0.60 µg/mL 15 µg/mL <4%
Online Phenobarbital (cobas c 311 analyzer) < 0.75 µg/mL 15 µg/mL <5%
Procainamide < 0.14 µg/mL 2 µg/mL <7%
Phenobarbital III < 0.6 µg/mL 12 µg/mL <5%
Phenytoin II < 0.5 µg/mL 10 µg/mL <5%
Quinidine < 0.14 µg/mL 2 µg/mL <7%
Salicylate < 2.5 µg/mL 50 µg/mL <5%
Theophylline II1 < 0.7 µg/mL 10 µg/mL <4%
Tobramycin < 0.10 µg/mL 2 µg/mL <5%
Total MPA < 0.05 µg/mL 1.0 µg/mL <5%
Valproic Acid II < 2.1 µg/mL 30 µg/mL <7%
< 0.7 µg/mL 10 - 40 µg/mL <7%
Vancomycin II
> 40 µg/mL < 12 %

1 Assay is not available on the cobas c 311 analyzer.

n = 21 for all tests

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